The Health Service Branded Medicines (Control of Prices and Supply of Information) Regulations 2008

Increases

5.—(1) The Secretary of State may either—

(a) on his own motion; or

(b) on application made under paragraph (2),

increase the maximum price of a presentation by direction to a specific manufacturer or supplier.

(2) An application by a specific manufacturer or supplier to the Secretary of State for an increase of the maximum price of a presentation shall be made in writing and shall—

(a) specify the presentation in respect of which the application is made;

(b) state the reasons for the application; and

(c) be accompanied by the information specified in paragraph (6).

(3) The Secretary of State shall, subject to paragraphs (4) and (5), within 90 days of receiving an application under this regulation either notify the applicant of his decision or notify the applicant that more information is required and, where further information is required, the Secretary of State shall notify the applicant of his decision within 90 days of receiving that further information.

(4) Where the number of applications received by the Secretary of State make it impracticable for him to reply to all or any of the applications within the 90 day period from their receipt, he shall notify the applicant before the end of that period.

(5) In a case where the Secretary of State has given notice under paragraph (4), he shall make a decision not later than 60 days after the expiry of the 90 day period from receipt of the application, or if he has required further information under paragraph (3), not later than 150 days after the receipt of that further information.

(6) Where an application is made under this regulation, audited accounts for the latest accounting year for which they are available shall be supplied to the Secretary of State, and those accounts shall include the figures for that year in respect of branded health service medicines which show—

(a) the supplies of those medicines for health service purposes;

(b) any supply promotion costs in respect of those medicines;

(c) any costs of research into, and development of, those medicines;

(d) any non-recurring operational costs;

(e) any other costs; and

(f) total profit after interest charges and taxation.

(7) Where an application is made under this regulation, estimates of accounts for the two accounting years which follow the most recent one in respect of which accounts are required to be provided under paragraph (6) shall be supplied to the Secretary of State, showing the information of the kind required under that paragraph.